Karyopharm Therapeutics Inc.

  • Manager, Clinical Supply Chain

    Job Locations US-MA-Newton
    Job ID
    2019-1368
    # of Openings
    1
    Category
    Other
    Type
    Regular Full-Time
  • Responsibilities

    This role is responsible for ensuring continuous product supply for Karyopharm’s drug products (IMP) in support of clinical trials.  The individual will work with internal and external customers and suppliers in order to accomplish project objectives. The individual will develop IMP packaging and distribution plans and manage Clinical Supplies documentation requirements. Responsible for monitoring inventory levels and providing feedback to the appropriate resources regarding expiry and resupply. In addition, the individual will support Clinical Supply Chain initiatives and continuous improvement activities.

     

    • Review clinical trial protocols and understand impact on supply
    • Partner with Clinical Operations to identify demand assumptions, such as enrollment rate, number of sites, number of countries, etc.
    • Create, review and update the clinical supply and demand plans based on strategic elements/study forecasts from Clinical Operations for studies and/or programs
    • Participate in cross-functional Project Team Meetings
    • Ensure changes in supply configuration, trial design, enrollment timelines, manufacturing availability and regulatory requirements are considered
    • Monitor inventory levels at depots and clinical sites through the life of a trial; take preventive actions to avoid potential supply issues
    • Manage label development process and packaging timelines
    • Coordinate US and international distribution and logistics with CMOs
    • Develop IRT and participate in User Acceptance Testing
    • Develop and maintain applicable metrics
    • Review and update SOPs and identify the need for an assist in establishing new departmental procedures

    Qualifications

    • Bachelor’s degree in life sciences or business major
    • 2+ years of pharmaceutical industry experience within clinical supply chain management (oncology and solid oral dosage form experience preferred).
    • Experience in CMO management, including labeling, packaging, and distribution in North America and Europe
    • Experience with IRT system and implementation
    • Knowledge of cGMPs and relevant FDA and EU Regulations
    • Familiarity with US and EU regulatory agencies and their guidance
    • Ability to communicate effectively both orally and in writing, both internally and with external vendors and partners
    • Ability to multi-task and work in a fast paced and dynamic environment
    • Strong working knowledge of standard business software, including MS Excel, Word, PowerPoint and Project
    • Strong analytical and organizational skills
    • Travel domestic and international – possibly up to 10%

     

     

    Overview

    Karyopharm Therapeutics is a global commercial-stage pharmaceutical company focused on the discovery and development of novel first-in-class drugs directed against nuclear transport targets for the treatment of cancer and other major diseases.

     

     

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